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OpenTrials
Completed

NCT Number: NCT00073593

Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Provide written informed consent before initiation of any study related procedures.
  • Be at least 18 years of age.
  • Be accepted for elective off-pump coronary artery bypass graft (CABG) surgery without concomitant cardiac surgical procedures.
  • < 4 planned Coronary Artery Bypass Grafts

Exclusion:

  • Any prior Cardio-Thoracic Surgical procedures requiring median sternotomy
  • Confirmed pregnancy - baseline urine or serum pregnancy test (if woman of childbearing potential).
  • Cerebrovascular accident within 6 months before randomization, or any cerebrovascular accident with residual neurological deficit.
  • Intracranial neoplasm, arteriovenous malformation, or aneurysm.
  • Dependency on renal dialysis or creatinine clearance <30mL/min.
  • Ongoing treatment with warfarin (or other oral anticoagulants) at the time of randomization. Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is <1.3 times control in the absence of heparin therapy.
  • Known allergy to Angiomax or hirudin derived drugs, or known sensitivity to any component of these products.
  • Patients receiving clopidogrel within the previous 5 days of randomization.
  • Patients receiving a glycoprotein IIb/IIIa inhibitor within 48 hours if abciximab (ReoPro) or within 24 hours if eptifibatide (Integrilin) and tirofiban (Aggrastat) of randomization
  • Patients receiving lepirudin or argatroban within the previous 24 hours of randomization.
  • Patients receiving low molecular weight heparin (LMWH) or thrombolytics within the previous 12 hours or unfractionated heparin within 30 minutes of randomization.
  • Patients with active or prior history of heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS)*.
  • Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization.
  • Refusal to undergo blood transfusion should it become necessary.
  • Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial or inability to comply with study requirements.

Treatment and study plan

Bivalirudin

Drug

250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) >300 seconds (s).

Heparin

Drug

: Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of >300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock.

Protamine

Drug

Per institutional practice. Batches from hospital stock.

Primary outcomes

  1. Death

    Time frame: Hospital discharge or Day 7

  2. Q-wave MI

    Time frame: hospital discharge or day 7,

  3. Repeat Coronary Revascularization,

    Time frame: hospital discharge or day 7,

  4. Stroke (hemorrhagic or ischemic).

    Time frame: hospital discharge or day 7

Sponsors and collaborators

Lead sponsor

The Medicines Company

Industry

Registry information

Official study title

A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery

Acronym: OPCAB

Important dates

Study start
2003
Primary completion
2004
First posted
Nov 27, 2003
Registry last updated
Nov 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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